Govt to regulate stem cell research including clinical trial and marketing

The Directorate General of Health Services has established a stem cell division to evaluate proposals concerning stem cell research, Health and Family Welfare Minister Ghulam Nabi Azad. Speaking in the Lok Sabha, Azad said the stem cell division was established within the Biological Division in Central Drugs Standard Control Organisation for the internal evaluation of all proposals, including stem cell concerning with clinical trial and marketing authorisation.

"Till recently, there was no mechanism in place to take note of the cases violating these guidelines or take action against the agencies found violating these guidelines. In a step towards this direction, Ministry of Health and Family Welfare vide order dated 1st September 2010 constituted a Core Investigational New Drug (IND) Panel of Experts namely "Cellular Biology Based Therapeutic Drug Evaluation Committee (CBBTDEC) under the chairmanship of Director General, ICMR & Secretary, DHR to advice DCGI in matters pertaining to regulatory pathways leading to the approval of clinical trials and market authorization for the "Therapeutic products derived from Stem Cell, human Gene manipulation and Xenotransplantation technology". CBBTDEC has deliberated on the need for strengthening the regulatory agency (DCGI) by establishing separate wing for Stem Cell Research supported with knowledge and capacity to regulate the activities in the country."

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